Multicomponent containers adapted for initially holding in separate compartments, two or more substances or materials such as medicaments, one being dry, and the other a liquid diluent or carrier solution for such dry components, have been known and used. A specific example of such a compound container of this general nature is disclosed in U.S. Pat. No. 4,550,825, assigned to a common assignee with the present application. Other examples of multicompartment medicament dispensers are, for example, disclosed in U.S. Pat. No. 4,410,321, issued Oct. 18, 1983. Numerous other examples are found in the prior art but many included one or more drawbacks in manufacture processing, effective long-life sealing of the individual containers or compartments, and a composite or compound unit being effectable by manufacture of the individual components in separate manufacturing or process lines, such containers being separately fillable with dry medicaments and diluents therefor and the individual containers being separately, if desired, stored and in some instances being effectively conjoined one with another for use or utilization by dispensers of the medicaments in I.V. systems or the like, such interconnected and sealed separate containers, when actively interjoined for storage, shipment, and use, being highly efficient and overcoming drawbacks in prior non-constructions.
In effecting or manufacture of a structure incorporating the present inventive concepts, a vial of glass is filled with a desired amount of powdered medicament and individually sealed, and a flexible container of plaastic material is filled selectively with a diluent and individually sealed in a sterile manner as is the powder container. The two containers are actively interconnected by seal means including an aluminum seal consisting of a pliable aluminum strip which is rolled over the juncture of the two separate and separely sealed containers.
The so-joined separate containers also preferably include hanger means operatively attached to the glass powder medicament container, and which can include labeling means for identification purposes and such labels can be removably mounted if desired. The seal between the two containers having the rolled aluminum seal is further enhanced or effected by incorporation therebetween of an elastomeric material gasket between glass and plastic material ports. A movable plug closes the flexible container and a so-called Lyo-stopper closes the port in the glass vial.
Means are included for effecting intercommunication of the liquid with the powdered medicament by pushing or moving both stoppers into the glass vial by means such as a push rod attached to or in contact with the stopper in the plastic diluent container.
Another of the problems heretofore existing in the interconnection of glass containers with plastic material containers resided in or was related to the use of adequate vapor barrier means in the two different material containers. The present invention utilizes for such vapor barriers, and sterile closure means, two plugs instead of a single one such as in some of the prior art structures and which were pierced or forced out of a port to effect intermixture. The two separate closure plugs constituting separate vapor barriers overcomes a problem of sealing capability over extended periods of time.
The present invention significantly is of a design to effect a good sealing of a plastic bag to a glass container, both the glass bottle or container with its own separate stopper is joined to a plastic neck on the plastic flexible diluent container bag, and the structure and materials are such that the two can be joined together by heat and/or sonic means and the like. Each of the containers is individually sealed and the two initially sealed containers are joined together by composite sealing means with aluminum flexible material spun over the juncture point therebetween, resulting in a compound unit of exceptional effectiveness, long lasting sealing, and both components of which can be produced in separate production lines, separately stored and thereafter effectively interconnected or joined and activated in an I.V. system with good and high effectivity, and in the absence of contamination or effective actuation of the medicament material as intermixed for use in such dispensing or introduction methods or systems.
Very broadly, in the preferred embodiment hereinafter described in detail, and as shown in the drawings, the basic concept of the invention is disclosed. A separate glass dry medicament or drug container is formed in a usual manner, and a plastic material diluent holding bag which is resilient is composed of two layers or sides of plastic material heatedly or otherwise appropriately interconnected. A resilient closure plug is fitted into the interior of the outlet port of the glass vial, and a port is formed in the plastic diluent structure by an elliptical or ellipsoidal-shaped plastic inert, which is inserted into the opened port of the flexible bag and appropriately sealed therein. The overall structure overcomes the problems encountered in joinder of glass with plastic materials by utilization of the elliptical portion of the plug in the diluent container bag. The use of the plastic ellipsoidal-shaped insert in the bag discharge port of a plastic material facilitates adherence of the plug and interconnection with the glass container through the aformentioned sealing means. Adhesion or affixing can utilize suitable adhesives, heat sealing and/or other known methods.
Broadly speaking, therefore, the present invention incorporates two separate material containing structures which are individually producible along separate production lines and each has a suitable closure plug, and means such as a push rod plunger actuator is incorporated in the plastic bag which, upon being displaced, will also displace the individual seals or plug members of the two containers for movement into the glass vial, and the diluents and dry medicament are thereafter permitted to intermix with no fragmentation or contamination.
Other objects and advantages of the present invention will become readily apparent from the following detailed description, wherein there is shown and described a preferred embodiment of the invention, simply by way of illustration of a preferred and presently contemplated mode for carrying out the invention. As will be realized, the invention is susceptible to minor modifications in various, obvious respects, all without departing from the invention. The drawings and description are to be regarded merely as illustrative in nature and not as restrictive.